Effect of Electroacupuncture on SAP With MODS

December 21, 2021 updated by: Jianbo Yu

Effect of Electroacupuncture on SAP With MODS: a Prospective, Double-blind, Randomized Controlled Trial

  1. Title: Effect of Electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome patients: A Randomized Clinical Trial
  2. Research center: single center
  3. Design of the research: A randomized, double-blind and parallel controlled study
  4. Object of the research: The patients over 18 years that met the criteria of SAP and with more than 2 organs failure.
  5. Sample size of the research: A total of 220patients,110 cases in each group
  6. Interventions: The acupuncture points for electroacupuncture are Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) points . Participants in the treatment group underwent 30 minutes acupuncture (0.30mm×70mm) at above points once a day for seven days. After"Deqi",electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained the end of treatment. Participants in the control group received shallow needling (0.30mm×25mm) at nonacupoints (located 1 inch beside acupoints). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.
  7. Aim of the research: To investigate the effect of electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome.
  8. Outcome #Primary outcomes: All-cause 28-day mortality. Secondary outcomes: Duration of organ failure; The incidence of pancreatic necrotic tissue infection; Time for enteral nutrition to reach the standard (30kcal/kg); Mechanical ventilation time; Length of hospital stay
  9. The estimated duration of the study#2 years.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, double-blinded, placebo controlled and long-term follow-up design. In this study, Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) were selected for electroacupuncture treatment, accompanied with evaluating the effects on 28-day mortality in SAP patients with MODS, as well as the duration of organ failure, the incidence of pancreatic necrotic tissue infection and length of hospital stay . To clarify the effect of electroacupuncture on SAP patients with MODS is of great significance to the clinical applications and popularization of traditional acupuncture treatment across the world.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Meet the diagnosis of severe acute pancreatitis (Atlanta diagnostic criteria), within 1 week of onset
  2. Combine 2 or more organ failures at the same time, and the duration is greater than 48h
  3. Age ≥18 years old;
  4. Obtain informed consent.

Exclusion Criteria:

  1. Pregnancy pancreatitis;
  2. Patients who have undergone percutaneous puncture or surgical drainage before admission, and have undergone surgical decompression due to early abdominal hypertension;
  3. Patients with a history of chronic organ dysfunction (such as uremia, COPD, liver cirrhosis, heart failure, etc.).
  4. Those who have a medical history of acupuncture and moxibustion or are not sensitive to acupuncture and moxibustion.
  5. Those who refuse to participate in the research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: electroacupuncture treatment
Participants in the treatment group underwent 30 minutes acupuncture (0.30mm×70mm) at Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) once a day for seven days. After"Deqi",electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) isconnected and maintained the end of treatment.
Device: electroacupuncture treatment
Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) once a day for seven days. After"Deqi", electroacupuncture stimulation apparatus(HANS G6805-2, Huayi Co, Shanghai, China) is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 ~ 30 mA (gradually increase to the patient's maximum tolerance) and maintained the end of treatment.
Sham Comparator: sham electroacupuncture treatment
Participants in the control group received shallow needling (0.30mm×25mm) at nonacupoints (located 1 inch beside acupoints). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.
Device: sham electroacupuncture treatment
Participants in the sham electroacupuncture group received shallow needling (0.30mm×25mm) at nonacupoints (located 1 inch beside acupoints).. Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output, and retained the needle for the same time as treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause 28-day mortality
Time Frame: 1-2year
All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments
1-2year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of organ failure
Time Frame: an average of 1-2 year
The time of organ failure recovered
an average of 1-2 year
Duration of mechanical ventilation in patients with endotracheal intubation in ICU
Time Frame: an average of 1 year
Duration of mechanical ventilation in patients with endotracheal intubation in ICU
an average of 1 year
Length of stay in hospital
Time Frame: 24 months
ICU stay time and hospitalization time
24 months
The incidence of pancreatic necrotic tissue infection
Time Frame: up to one year
The incidence of pancreatic necrotic tissue infection
up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jianbo Yu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 22, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA-SAP-202103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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